FDA hosted an all-day public hearing to gain feedback on its 510(k) process, looking specifically at issues of predicate devices, new technologies, submission volume and post-market surveillance. The event was webcast and opened to a packed house – in his intro, CDRH director Dr. Jeff Shuren said there were more than 400 people in attendance, plus the web audience – one indication of the attention 510(k) reform is receiving from industry, the media and the public. Shuren added that due to this response, the 510(k) comment period was extended to March 19th.
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